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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Brainlab Origin Data Management Software Recalled for Patient Record Errors

Agency Publication Date: March 18, 2025
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Summary

Brainlab AG has recalled versions 3.1 and 3.2 of its Origin Data Management software. This software is used by healthcare providers to manage patient medical information and records. The recall was initiated because records from unrelated individuals can be automatically merged into a single patient record without any notification to the user. No injuries have been reported to date, but patients and providers should follow the recommended corrective actions immediately.

Risk

The software defect causes data from different patients to be combined, which could lead to medical professionals viewing or treating a patient based on the wrong medical history. This poses a risk of incorrect diagnoses, improper surgical planning, or other serious medical errors.

What You Should Do

  1. This recall affects Brainlab Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, and 3.2.1.
  2. Identify if your facility is using the affected software by checking the version number and the system identifiers: 04056481145118 (for version 3.1) or 04056481146078 (for version 3.2).
  3. Stop using the recalled software immediately to prevent the risk of silent patient record merging.
  4. Contact Brainlab AG or your authorized medical device distributor to arrange for a software correction, replacement, or update.
  5. Call the FDA's medical device information line at 1-888-463-6332 if you have further questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Origin Data Management software (v3.1)
Variants: Version 3.1.0, Version 3.1.1, Version 3.1.2
Model / REF:
3.1.0
3.1.1
3.1.2
UDI:
04056481145118

Recall number Z-1392-2025

Product: Origin Data Management software (v3.2)
Variants: Version 3.2.0, Version 3.2.1
Model / REF:
3.2.0
3.2.1
UDI:
04056481146078

Recall number Z-1392-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96241
Status: Active
Manufacturer: Brainlab AG
Sold By: Brainlab AG; Authorized medical device distributors
Manufactured In: Germany
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.